Fertility tracking has been a popular segment of digital health, demonstrated by the likes of startups such as Glow, Trak Fertility and Welltwigs. Fertility apps in general have attracted a new surge of interest with the Zika virus and the desire by some women to use these kinds of apps to avoid getting pregnant, especially in areas affected by the Zika virus. Unfortunately, many of the apps available to the public lack the kind of clinical validation to ensure the information they provide is consistently accurate. Some digital health companies have sought FDA clearance or are looking to shift their direction. Bloomlife falls under the former category.
The San Francisco-based startup, which also has an office in Belgium, has raised $4 million in seed funding, according to an emailed news release. New investors include Salesforce founder Marc Benioff and the opportunistic early stage fund Efficient Capacity, Kapor Capital, CAA Ventures, Liquid 2 Ventures, and Belgian private equity firm Meuinvest, noted Bloomlife CEO and Co-founder Eric Dy, in response to emailed questions. Other investors taking part in the seed round included LanzaTech Ventures, The Chernin Group,and Act One Ventures. To date, Bloomlife has raised $6 million.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Dy said the company would use the new funding to support the launch of its product — a clinically validated wearable sensor to automatically track and count contractions safely from home. It is geared to expectant mothers in their third trimester. The seed funding will also be used to “accelerate development and clinical validation of the next features on the wearable platform” including fetal movement and maternal health, physical activity, stress, and sleep, Dy wrote. He noted that the company is on course to submit an application to the U.S. Food and Drug Administration for 510(k) clearance in 2017.
Bloomlife’s direct competitors include The Nuvo Group and Monica Healthcare. Although there are pregnancy monitoring products and fertility tech used within clinical practice, Dy sees a growing interest in companies developing products of value to clinicians and consumers.
Given the company’s interest in getting FDA approval, and seeing other companies such as Sense4Baby and sperm counter Sandstone Therapeutics that have done the same, I asked Dy if he noticed more companies seeking FDA clearance. Dy said he doesn’t really see it but believes it will be a long-term trend.
“The lack of clinical validation is a broad problem within digital health, it’s perhaps even more so with fertility tracking apps and Zika,” Dy said. “Over the long-term I believe there will be a general trend towards more clinical validation and seeking of FDA clearance. This ultimately gives companies greater opportunity for endorsement and adoption within healthcare systems. In the near term though, I expect most will avoid clinical validation since it’s time-consuming and doesn’t provide an immediate ROI.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Dy observed that when it comes to emerging trends in the fertility space, healthcare companies are beginning to catch on to the opportunities in family planning and early parenthood opportunities that have spurred retailers to gear their marketing to attract pregnant women.
